Composition :

Each tablet NORESTIL® contain Norethisterone 5 mg


Pharmacology :

Norethisterone is a powerful progestogen with weak androgenic side effects. Complete endometrial changes from proliferative stage to secretory stage can be achieved by oral administration of Norethisterone 100-150 mg per cycle. Progestogenic effect of Norethisterone on the basic endometrium is as a basic therapy in dysfunctional bleeding, primary and secondary amenorrhea and endometriosis.

Inhibition of gonadotropin and anovulatory secretions can be achieved by administering 0.5 mg of Norethisterone per day. The positive effects of Norethisterone on premenstrual symptoms can be traced back to the suppression of ovarian function. Norethisterone stabilizes the endometrium so administration Norethisterone can be used to regulate the menstrual cycle. Like progesterone, Norethisterone has a thermogenic effect and regulates the basal body temperature.


Indication :

Dysfunctional uterine haemorrhage, primary and secondary amenorrhea, pre-menstrual syndrome, clinical mastopathy, menstrual setting, endometriosis.


Dosage :

Tablets swallowed with drinking water. The efficacy of Norethisterone may be reduced if the patient forgets to take the tablets given. Tablets that forget to drink should be taken as soon as possible before continuing the next tablet. If contraception is needed for protection, should be used non-hormonal contraceptive.

  • Dysfunctional uterine bleeding: 1 tablet of Norethisterone is given 3 times per day for 10 days. In many cases, uterine bleeding unrelated to an organic lesion will stopped within 1-3 days, however, to achieve optimal results, Norethisterone should be administered for 10 days. Approximately after 2-4 days of complete therapy, will occur withdrawl bleeding with intensity and duration such as normal menstruation. Occasionally, mild bleeding may occur after initial bleeding stops. In some cases, tablet administration should not be delayed or stopped. If vaginal bleeding does not stop, even if tablet administration is appropriate, other causal factors such as organic or extragenital factors (eg polyps, uterine cervical carcinoma, myoma, abortal remains, uterine ovarian or coagulation disorders) should be considered. In cases where after the initial bleeding stopping, occasional bleeding occurs much during the administration of the tablet. To prevent the occurrence of dysfunctional bleeding in patients with anovulatory cycles, give Norethisterone as a prophylactic 1 tablet 1-2 times per day starting on the 16th day until the 25th day of the cycle (the first day of the cycle equals the first day of the last bleeding). Withdrawl bleeding occurs within a few days after administration of the last tablet.
  • Primary and secondary amenorrhea: Hormone therapy may be given to secondary amenorrhea only outside of pregnancy. Before starting therapy in primary or secondary amenorrhea, it is best to remove the pituitary tumor that produces prolactin. It is unlikely that there is an increase in the size of the macroadenoma when exposed to high-dose estrogens for some time. The basal endometrium with estrogen should be excluded (eg for 14 days) before the initiation of Norethisterone therapy. After that, 1 tablet of Norethisterone is given 1-2 times per day for 10 days. Withdrawl bleeding occurs within a few days after administration of the last tablet. In patients with adequate endogenous estrogen production, it can be discontinued estrogen therapy and bleeding cycle induction by administering 1 tablet of Norethisterone 2 times per day starting on the 16th day until the 25th day of the cycle.
  • Pre-menstrual syndrome, cyclic mastopathy: given 1 tablet of Norethiosterone 1-3 times per day during the luteal phase of the cycle of the possibility of reducing or improving premenstrual signs such as headache, depressive mood, fluid retention and full feeling in the breast.
  • Menstrual regulation: Menstrual bleeding each month may be delayed by Norethisterone administration. However, this method should be used with caution in patients at risk of not becoming pregnant during the therapy cycle.

Dose: 1 tablet of Norethisterone 2-3 times per day not more than 10-14 days starting approximately 3

days before the estimated menstruation. Bleeding will occur within 2-3 days after treatment is stopped.

  • Endometriosis : Treatment should be given between the first day and the 5th day of the cycle with 1 tablet of Norethisterone 2 times per day. If bleeding occurs, the dose may be increased to 2 tablets 2 times per day. If there is bleeding, think about to reduce the initial dose. Therapy is continued for at least 4-6 months. With uninterrupted daily giving, no ovulation and bleeding occur. After the hormone is stopped, there will be bleeding.


Presentation and Registration Number:

NORESTIL® Box, 3 strips @ 10 tablets; DKL1108016710A1





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